About Us
Our history
PrimePath Regulatory was founded to meet a growing need for integrated, strategic, and science-driven regulatory expertise in an increasingly complex global environment. Built on decades of experience in regulatory affairs, medical and scientific writing, CMC, and nonclinical strategy, PrimePath was established to bridge the gap between development and approval — helping companies move efficiently from concept to market.
The firm’s origins trace to the leadership and vision of its founder,
Dr. Stephen J. Lombardi, whose career spans global submissions across the U.S., EU, and key international markets. Drawing on this foundation, PrimePath was designed as a lean, senior-led consultancy — delivering the agility of a focused team with the depth of global regulatory experience.
Our mission
PrimePath Regulatory empowers biopharmaceutical innovators to navigate the global regulatory landscape with clarity, confidence, and purpose.
We combine strategic insight, scientific excellence, and collaborative execution to accelerate the development and approval of therapies that improve lives worldwide — transforming regulatory complexity into a clear path to success.
